Higher radiation doses guided by hypoxia scans for head and neck cancer
Tests extra radiation to low-oxygen tumor areas in head and neck cancer.
Plain-language title generated from the registry record
Registry title: FMISO-based Adaptive Radiotherapy for Head and Neck Cancer
Key facts
- Where
- Brno, Olomouc, and Ostrava, CzechiaSee the 3 sites
Where in Czechia
- The Masaryk Memorial Cancer InstituteBrno, CzechiaTaking people
- Radiation oncology department in Palacký University and University Hospital OlomoucOlomouc, CzechiaTaking people
- Faculty Hospital OstravaOstrava, CzechiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital Olomouc
- Trial code
- NCT05348486
- Record updated
- 22 April 2025
- Original description
Hypoxia occurs in about 80% of head and neck tumors. Based on experimental and clinical data, hypoxia is a useful parameter for pretherapeutic stratification. These radioresistant regions can be detected with FMISO PET/CT. Moreover, hypoxic subvolumes of tumors can be evolving as target volumes for radiotherapy ("dose painting") in hypoxia imaging-based dose escalation.Read full original descriptionShow less
FMISO-based Adaptive Radiotherapy for Head and Neck Cancer - a Prospective Multicenter Study
Hypoxia occurs in about 80% of head and neck tumors. Based on experimental and clinical data, hypoxia is a useful parameter for pretherapeutic stratification. These radioresistant regions can be detected with FMISO PET/CT. Moreover, hypoxic subvolumes of tumors can be evolving as target volumes for radiotherapy ("dose painting") in hypoxia imaging-based dose escalation.
Inclusion: Pathologically proven new diagnosis of oropharyngeal p16 negative, or laryngeal, hypopharyngeal, oral cavity (independent of p16) squamous cell carcinoma of clinical stage III, IV confined to head and neck area; Evaluable tumor burden assessed by computed tomography scan or magnetic resonance imaging, based on RECIST (Response Evaluation Criteria in Solid Tumours) version 1.1; Eligibiity for definitive chemoradiation or hyperfractionated accelerated radiotherapy; Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; Adequate kidney and liver function.
Exclusion: Prior surgical treatment - any surgery of primary tumor or involved nodes or prior surgical debulking apart from surgery with diagnostic intention (e.g. open biopsy if necessary); Prior systemic therapy, targeted therapy, radiotherapy treatment for head and neck cancer; History of a diagnosed and/or treated hematologic or primary solid tumor malignancy, unless in remission for at least 5 years prior to randomization; Previous allogeneic tissue/solid organ transplant; Cancer outside of the oropharynx, larynx, and hypopharynx or oral cavity, such as nasopharyngeal, sinus, other para-nasal, or unknown primary head and neck cancer; Known active Hepatitis B or C; History of Human Immunodeficiency Virus (HIV); Active infection requiring systemic therapy; Known active central nervous system (CNS) metastases and/or carcinomatous meningitis or any distant metastasis.